Transcendental Meditation and Reduced Trauma Symptoms in Women Inmates

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

Transcendental Meditation and Reduced Trauma Symptoms in Women Inmates: A Randomized Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791464
• Other study ID #: DLF1008
• Status: Completed
• Phase: N/A
• First received: June 1, 2016
• Last updated: June 3, 2016
• Start date: March 2014
• Est. completion date: August 2014

Study information

• Verified date: June 2016
• Source: Maharishi University of Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The pilot study investigates the potential benefits of the Transcendental Meditation program in reducing trauma, including PTSD, in female prisoners. Subjects will be randomly assigned to either the TM program or a wait list control group for a period of four months.

Description:

This randomized controlled pilot study will evaluate the effects of Transcendental Meditation ® (TM) on female offenders with trauma. Twenty-two inmates at the Coffee Creek Correctional Facility in Wilsonville, Oregon, with at least four months left of incarceration, will be enrolled in the study. Subjects will be randomly assigned to either a TM (n=11) or a wait-list control group (n=11). Subjects will be measured at baseline and four-month posttest, using the Posttraumatic Stress Disorder Checklist-Civilian version (PCL-C) Twenty of the subjects (10 in each group) will take part in their treatment assignment and complete post-testing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• female inmates, at least 4 months left of incarceration, signed written informed consent prior to baseline testing

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Transcendental Meditation program
a mental technique using a mantra or 'soothing sound' that refines the thought process enabling the mind to 'transcend' its own thinking process and experience a state of pure consciousness. Subjects practice this technique twice a day for 20 minutes sitting in chair with eyes closed.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Maharishi University of Management	Maharishi University of Management Research Institute, Western Oregon University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posttraumatic Stress Checklist- Civilian Version (PCL-C) total score	The PCL-C is a widely-used 17-item self-report questionnaire of trauma symptom with total score and intrusions, avoidance and hyperarousal subscales	4 months	No